Pain free defibrillation threshold estimation

ABSTRACT

A system and method for painlessly calculating an estimated defibrillation threshold, such as by using an implantable medical device and a controller. The estimated defibrillation threshold can be calculated using a delivered first energy to a first thoracic location, an electric field detected at a second thoracic location, and an electric field detected between a third thoracic location and a fourth thoracic location. The estimated defibrillation threshold represents an energy that, when delivered at the first thoracic location, can create an electric field strength in a target region of the heart that meets or exceeds a target electric field strength.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to the commonly assigned Wei et al. U.S.patent application Ser. No. 11/208,923 entitled “DEFIBRILLATIONTHRESHOLD PREDICTION METHODS AND SYSTEMS,” (herein “Wei et al. '923”)filed on Aug. 22, 2005; and the commonly assigned Daum et al. U.S. Pat.No. 6,751,502 entitled “CARDIAC RHYTHM MANAGEMENT SYSTEM WITHDEFIBRILLATION THRESHOLD PREDICTION,” (herein “Daum et al. '502”) filedon Sep. 19, 2002; the disclosures of which are hereby incorporated byreference.

TECHNICAL FIELD

This patent document pertains generally to implantable medical devices,and more particularly, but not by way of limitation, to defibrillationthreshold estimation.

BACKGROUND

When functioning properly, a heart maintains its own rhythm and iscapable of pumping a sufficient amount of blood throughout a subject'scirculatory system. However, some subjects may have cardiac arrhythmia.Generally, cardiac arrhythmia is a condition or group of conditionscharacterized by an irregular cardiac rhythm. In certain examples,cardiac arrhythmia can result in a diminished blood circulationthroughout the body.

A cardiac arrhythmia can be treated using a cardiac rhythm managementsystem. A cardiac rhythm management system can include an implantable orexternal system or device, such as a defibrillator, configured todeliver therapy, such as an electric stimulus, to the heart. Generally,a defibrillator can be used to deliver an electric stimulus, typicallyreferred to as a defibrillation countershock or shock. Thedefibrillation countershock can interrupt an abnormal heart rhythm,allowing the heart to reestablish normal rhythm.

One problem faced by a cardiac rhythm management system is thedetermination of a threshold energy required, for a particulardefibrillation shock waveform, to reliably convert an abnormal heartrhythm to normal heart rhythm. Ventricular fibrillation and atrialfibrillation are probabilistic phenomena that generally observe adose-response relationship with respect to shock strength. Theventricular defibrillation threshold is the smallest amount of energythat can be delivered to the heart to reliably revert ventricularfibrillation or fast ventricular tachycardia to normal rhythm.Similarly, the atrial defibrillation threshold is the threshold amountof energy that will reliably terminate an atrial fibrillation. Thedefibrillation thresholds can vary from subject to subject, and may evenvary within a subject depending on the placement of a lead or anelectrode used to deliver the energy or depending on the subject'scondition.

One technique for determining a defibrillation threshold includesinducing a targeted tachyarrhythmia (e.g., ventricular fibrillation),and then applying one or more than one shock of varying magnitude todetermine the energy needed to convert the arrhythmia to normal heartrhythm. However, this technique requires imposing the risks anddiscomfort associated with both the arrhythmia and the defibrillation.Electric energy delivered to the heart has the potential to both causemyocardial injury or pain. As a result, anesthesia is generallyrequired, adding an additional logistic barrier for implementation.Moreover, if defibrillation thresholds are being obtained in order toassist a physician in determining an optimal lead placement, thesedisadvantages are compounded as the procedure is repeated for differentpotential lead placements.

Another technique for determining the defibrillation threshold, referredto as the “upper limit of vulnerability” technique, includes shocking asubject that is in a state of normal heart rhythm during a vulnerableperiod of the cardiac cycle. The vulnerable period is generally a periodwhen the heart tissue is undergoing repolarization, e.g., a R-waveperiod. Typically, one or more than one shock of varying magnitude isapplied until fibrillation is induced. After such fibrillation isinduced, the subject must again be shocked in order to interrupt thearrhythmia and reestablish normal heart rhythm. In this technique, thecorresponding fibrillation-inducing shock magnitude is related, througha theoretical model, to a defibrillation threshold energy. The upperlimit of vulnerability technique also suffers from imposing the risksand discomfort associated with both the arrhythmia and thedefibrillation shock.

Moreover, because of the discomfort associated with the fibrillation andshocks, the subject is typically sedated under general anesthesia, whichitself imposes additional risk and increased cost. For these and otherreasons, the present inventor has recognized a need to estimate adefibrillation threshold without relying on a defibrillationcountershock to induce or terminate an actual arrhythmia.

OVERVIEW

This document discusses, among other things, a system and method forpainlessly calculating an estimated defibrillation threshold using animplantable medical device and a controller. The implantable medicaldevice can include a first energy delivery circuit, a second energydelivery circuit, a first electric field detector, and a second electricfield detector. The estimated defibrillation threshold can be calculatedusing a delivered first energy to a first thoracic location, an electricfield detected at a second thoracic location, and an electric fielddetected between a third thoracic location and a fourth thoraciclocation. The estimated defibrillation threshold represents an energythat, when delivered at the first thoracic location, can create anelectric field strength in a target region of the heart that meets orexceeds a target electric field strength.

In Example 1, a system includes an implantable medical device and animplantable or external controller. The implantable medical deviceincludes a first energy delivery circuit, configured to deliver anondefibrillating and nonfibrillation-inducing energy to a firstthoracic location, wherein the first thoracic location includes at leastone thoracic location, a first electric field detector, configured todetect an electric field, from the delivered nondefibrillating andnonfibrillation-inducing energy to the first thoracic location, at asecond thoracic location, wherein the second thoracic location includesat least one thoracic location, and a second electric field detector,configured to detect an electric field between a third thoraciclocation, which is at or near the first thoracic location, and a fourththoracic location, which is at or near the second thoracic location. Theimplantable or external controller is communicatively coupled to thefirst energy delivery circuit, the first electric field detector, andthe second electric field detector, and is configured to calculate anestimated defibrillation threshold using the nondefibrillating andnonfibrillation-inducing energy delivered to the first thoraciclocation, the electric field detected at the second thoracic location,and the electric field detected between the third thoracic location andthe fourth thoracic location.

In Example 2, the first energy delivery circuit of Example 1 optionallyincludes at least one of a voltage source and a current source, and isoptionally configured to deliver at least one of a voltage and a currentusing at least one first electrode and at least one second electrode.

In Example 3, the first thoracic location of Examples 1-2 optionallyincludes in, on, or near a first chamber of a heart.

In Example 4, the first thoracic location of Examples 1-3 optionallyincludes a location in, on, or near at least one of a right ventricle ofthe heart, a superior vena cava, an internal pectoral region, and aninternal abdominal region.

In Example 5, the second thoracic location of Examples 1-4 optionallyincludes a location in, on, or near at least one of an apical region ofa heart and a lateral wall of the heart.

In Example 6, the second thoracic location of Examples 1-5 optionallyincludes a location in, on, or near at least one of a left apical regionof the heart and a left ventricular free lateral wall of the heart.

In Example 7, the estimated defibrillation threshold (“VDFT1 _(est)”) ofExamples 1-6 is optionally calculated using the equation:

${{{VDFT}\; 1_{est}} = {V_{1}\frac{A}{\nabla V_{2}}\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}}},$wherein V₁ includes the nondefibrillating and nonfibrillation-inducingenergy delivered to the first thoracic location, wherein A is theminimal potential gradient for a successful defibrillation, wherein ∇V₂includes the resulting response signal detected at the second thoraciclocation, wherein V₃₋₄ includes the electric field detected between thethird thoracic location and the fourth thoracic location, and wherein aand b are coefficients.

In Example 8, the coefficients a and b of Examples 1-7 are optionallycalculated using a relationship between at least one knowndefibrillation threshold and the detected second electric field.

In Example 9, the controller of Examples 1-8 is optionally configured tocalculate an estimated defibrillation threshold using thenondefibrillating and nonfibrillation-inducing energy delivered to thefirst thoracic location and the electric field detected at the secondthoracic location, and wherein the controller is configured to adjustthe estimated defibrillation threshold using the electric field detectedbetween the third thoracic location and the fourth thoracic location.

In Example 10, the estimated defibrillation threshold (“VDFT2 _(est)”)of Examples 1-9 is optionally calculated using the equation:

${{{VDFT}\; 2_{est}} = {V_{1}\frac{A}{\nabla V_{2}}}},$wherein V₁ includes the nondefibrillating and nonfibrillation-inducingenergy delivered to the first thoracic location, wherein A is theminimal potential gradient for a successful defibrillation, wherein ∇V₂includes the electric field detected at the second thoracic location,and wherein the adjusted estimated defibrillation threshold(“VDFT_(adj)”) is calculated using the equation:

${{VDFT}_{adj} = {{VDFT}\; 2_{est}\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}}},$wherein V₃₋₄ includes the signal detected between the third thoraciclocation and the fourth thoracic location, and wherein a and b arecoefficients.

In Example 11, the coefficients a and b of Examples 1-10 are optionallycalculated using a relationship between at least one knowndefibrillation threshold and the detected second electric field.

In Example 12, the first electric field detector of Examples 1-11optionally includes the second electric field detector.

In Example 13, the detected electric field between the third thoraciclocation and the fourth thoracic location of Examples 1-12 optionallyincludes an electric field from the delivered nondefibrillating andnonfibrillation-inducing energy to the first thoracic location.

In Example 14, the implantable medical device of Examples 1-13optionally includes a second energy delivery circuit, communicativelycoupled to the controller, wherein the second energy delivery circuit isconfigured to deliver a nondefibrillating and nonfibrillation-inducingenergy to a fifth thoracic location, wherein the fifth thoracic locationincludes at least one thoracic location. The electric field detectedbetween the third thoracic location and the fourth thoracic location ofExamples 1-13 also optionally includes an electric field, from thedelivered nondefibrillating and nonfibrillation-inducing energy to thefifth thoracic location, between the third thoracic location and thefourth thoracic location.

In Example 15, the fifth thoracic location of Examples 1-14 isoptionally at or near at least one of the first thoracic location andthe third thoracic location.

In Example 16, the system of Examples 1-15 optionally includes at leastone lead, configured to couple at least one of the first energy deliverycircuit, the first electric field detector, and the second electricfield detector to at least one of the first thoracic location, thesecond thoracic location, the third thoracic location, and the fourththoracic location, and wherein the at least one lead includes at leastone electrode.

In Example 17, the at least one electrode of Examples 1-16 is optionallyconfigured in a first electrode configuration. The controller ofExamples 1-16 is optionally configured to select a second electrodeconfiguration, calculate a second estimated defibrillation threshold forthe second electrode configuration, compare the second estimateddefibrillation threshold to another estimated defibrillation threshold,and select an estimated defibrillation threshold using at least one ofthe second estimated defibrillation threshold and the other estimateddefibrillation threshold.

In Example 18, the system of Examples 1-17 optionally includes at leastone first electrode, configured to couple the first energy deliverycircuit to the first thoracic location, and at least one secondelectrode, configured to couple the first electric field detector to thesecond thoracic location.

In Example 19, the system of Examples 1-18 optionally includes at leastone third electrode, configured to couple the second electric fielddetector to the third thoracic location, and at least one fourthelectrode, configured to couple the second electric field detector tothe fourth thoracic location.

In Example 20, the first electrode of Examples 1-19 optionally includesthe third electrode. The second electrode of Examples 1-19 alsooptionally includes the fourth electrode.

In Example 21, the controller of Examples 1-20 is optionally configuredto compare at least one of the electric field detected at the secondthoracic location to at least one previous electric field detected atthe second thoracic location to detect a change in the detected electricfield, the electric field detected between the third thoracic locationand the fourth thoracic location to at least one previous electric fielddetected between the third thoracic location and the fourth thoraciclocation to detect a change in the detected electric field, and theestimated defibrillation threshold to a previous estimateddefibrillation threshold to detect a change in the estimateddefibrillation threshold.

In Example 22, the controller of Examples 1-21 is optionally configuredto detect a change in the estimated defibrillation threshold using atleast one of the detected change in the detected electric field at thesecond thoracic location and the detected change in the electric fieldbetween the third thoracic location and the fourth thoracic location.

In Example 23, the system of Examples 1-22 optionally includes anotification module, communicatively coupled to the controller, whereinthe notification module is configured to provide a notification usinginformation from the controller.

In Example 24, the system of Examples 1-23 optionally includes at leastone of an implantable or external heart signal sensing circuit,communicatively coupled to the controller, configured to sense a heartsignal of a heart, and an implantable or external respiration sensor,communicatively coupled to the controller, configured to sense arespiration signal. The first energy delivery circuit of Examples 1-23is also optionally configured to deliver the nondefibrillating andnonfibrillation-inducing energy to the first thoracic location at aspecified portion of at least one of the heart signal of the heart andthe respiration signal.

In Example 25, the system of Examples 1-24 optionally includes at leastone of an implantable or external heart signal sensing circuit,communicatively coupled to the controller, configured to sense a heartsignal of a heart, and an implantable or external respiration sensor,communicatively coupled to the controller, configured to sense arespiration signal. The first electric field detector or the secondelectric field detector of Examples 1-24 is also optionally configuredto detect an electric field at a specified portion of at least one ofthe heart signal of the heart and the respiration signal.

In Example 26, the controller of Examples 1-25 is optionally configuredto compare the estimated defibrillation threshold to a threshold.

In Example 27, a system includes means for delivering a firstnondefibrillating and nonfibrillation-inducing energy to a firstthoracic location, such as by using the first energy delivery circuit,wherein the first thoracic location includes at least one thoraciclocation, such as in, on, or near at least one of a first chamber of aheart, a right ventricle of the heart, a superior vena cava, an internalpectoral region, and an internal abdominal region. The system alsoincludes means for detecting an electric field, from the delivered firstnondefibrillating and nonfibrillation-inducing energy to the firstthoracic location, such as by using the first electric field detector,at a second thoracic location, such as in, on, or near at least one of aleft apical region of the heart and a left ventricular free lateral wallof the heart, wherein the second thoracic location includes at least onethoracic location. The system also includes means for detecting anelectric field between a third thoracic location, which is at or nearthe first thoracic location, and a fourth thoracic location, which is ator near the second thoracic location, such as by using the secondelectric field detector, and further, means for calculating an estimateddefibrillation threshold using the first nondefibrillating andnonfibrillation-inducing energy delivered to the first thoraciclocation, the electric field detected at the second thoracic location,and the electric field detected between the third thoracic location andthe fourth thoracic location, such as by using the implantable orexternal controller.

In Example 28, a method includes delivering a first nondefibrillatingand nonfibrillation-inducing energy to a first thoracic location,wherein the first thoracic location includes at least one thoraciclocation, detecting an electric field, from the delivered firstnondefibrillating and nonfibrillation-inducing energy to the firstthoracic location, at a second thoracic location, wherein the secondthoracic location includes at least one thoracic location, detecting anelectric field between a third thoracic location, which is at or nearthe first thoracic location, and a fourth thoracic location, which is ator near the second thoracic location, and calculating an estimateddefibrillation threshold using the first nondefibrillating andnonfibrillation-inducing energy delivered to the first thoraciclocation, the electric field detected at the second thoracic location,and the electric field detected between the third thoracic location andthe fourth thoracic location.

In Example 29, the delivering the first nondefibrillating andnonfibrillation-inducing energy to the first thoracic location ofExample 28 optionally includes delivering at least one of a voltage anda current using at least one first electrode and at least one secondelectrode.

In Example 30, the delivering the first nondefibrillating andnonfibrillation-inducing energy to the first thoracic location ofExamples 28-29 optionally includes delivering the firstnondefibrillating and nonfibrillation-inducing energy in, on, or near afirst chamber of a heart.

In Example 31, the delivering the first nondefibrillating andnonfibrillation-inducing energy in, on, or near the first chamber of theheart of Examples 28-30 optionally includes delivering the firstnondefibrillating and nonfibrillation-inducing energy in, on, or near atleast one of a right ventricle of the heart, a superior vena cava, aninternal pectoral region, and an internal abdominal region.

In Example 32, the detecting the electric field at the second thoraciclocation of Examples 28-31 optionally includes detecting the electricfield in, on, or near at least one of an apical region of a heart and alateral wall of the heart.

In Example 33, the detecting the electric field in, on, or near at leastone of an apical region of the heart and the lateral wall of the heartof Examples 28-32 optionally includes detecting the electric field in,on, or near at least one of a left apical region of the heart and a leftventricular free lateral wall of the heart.

In Example 34, the calculating the estimated defibrillation threshold(“VDFT1 _(est)”) of Examples 28-33 optionally includes using theequation:

${{{VDFT}\; 1_{est}} = {V_{1}\frac{A}{\nabla V_{2}}\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}}},$wherein V₁ includes the first nondefibrillating andnonfibrillation-inducing energy delivered to the first thoraciclocation, wherein A is the minimal potential gradient for a successfuldefibrillation, wherein ∇V₂ includes the resulting response signaldetected at the second thoracic location, wherein V₃₋₄ includes theelectric field detected between the third thoracic location and thefourth thoracic location, and wherein a and b are coefficients.

In Example 35, the determining coefficients a and b of Examples 28-34optionally includes using a relationship between at least one knowndefibrillation threshold and the detected second electric field.

In Example 36, the calculating an estimated defibrillation threshold ofExamples 28-35 optionally includes using the first nondefibrillating andnonfibrillation-inducing energy delivered to the first thoracic locationand the electric field detected at the second thoracic location. Themethod of Examples 28-35 also optionally includes calculating anadjusted estimated defibrillation threshold using the electric fielddetected between the third thoracic location and the fourth thoraciclocation.

In Example 37, the calculating the estimated defibrillation threshold(“VDFT2 _(est)”) of Examples 28-36 optionally includes using theequation:

${{{VDFT}\; 2_{est}} = {V_{1}\frac{A}{\nabla V_{2}}}},$wherein V₁ includes the first nondefibrillating andnonfibrillation-inducing energy delivered to the first thoraciclocation, wherein A is the minimal potential gradient for a successfuldefibrillation, wherein ∇V₂ includes the electric field detected at thesecond thoracic location; and wherein calculating the adjusted estimateddefibrillation threshold (“VDFT_(adj)”) includes using the equation:

${{VDFT}_{adj} = {{VDFT}\; 2_{est}\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}}},$wherein V₃₋₄ includes the signal detected between the third thoraciclocation and the fourth thoracic location, and wherein a and b arecoefficients.

In Example 38, the determining coefficients a and b of Examples 28-37optionally includes using a relationship between at least one knowndefibrillation threshold and the detected second electric field.

In Example 39, the detecting the electric field at the second thoraciclocation and detecting the electric field between the third thoraciclocation and the fourth thoracic location of Examples 28-38 optionallyincludes using at least one electric field detector.

In Example 40, the detecting the electric field between the thirdthoracic location and the fourth thoracic location of Examples 28-39optionally includes detecting the electric field from the deliveredfirst nondefibrillating and nonfibrillation-inducing energy.

In Example 41, the method of Examples 28-40 optionally includesdelivering a second nondefibrillating and nonfibrillation-inducingenergy to a fifth thoracic location, wherein the fifth thoracic locationincludes at least one thoracic location. The detecting the electricfield between the third thoracic location and the fourth thoraciclocation of Examples 28-40 also optionally includes detecting theelectric field from the delivered second nondefibrillating andnonfibrillation-inducing energy.

In Example 42, the delivering the second nondefibrillating andnonfibrillation-inducing energy to the fifth thoracic location ofExamples 28-41 optionally includes delivering the secondnondefibrillating and nonfibrillation-inducing energy at or near atleast one of the first location and the third location.

In Example 43, at least one of delivering the first nondefibrillatingand nonfibrillation-inducing energy to the first thoracic location,detecting the electric field at the second thoracic location, anddetecting the electric field between the third thoracic location and thefourth thoracic location of Examples 28-42 optionally includes using atleast one lead.

In Example 44, the delivering the first nondefibrillating andnonfibrillation-inducing energy to the first thoracic location ofExamples 28-43 optionally includes using at least one first electrode;and wherein detecting the electric field at the second thoracic locationincludes using at least one second electrode.

In Example 45, the detecting the electric field between the thirdthoracic location and the fourth thoracic location of Examples 28-44optionally includes using at least one third electrode and at least onefourth electrode.

In Example 46, the using the at least one first electrode of Examples28-45 optionally includes using the at least one third electrode; andwherein using the at least one second electrode includes using the atleast one fourth electrode.

In Example 47, the delivering the first nondefibrillating andnonfibrillation-inducing energy to the first thoracic location,detecting the electric field at the second thoracic location, anddetecting the electric field between the third thoracic location and thefourth thoracic location of Examples 28-46 optionally includes using atleast one electrode configured in a first electrode configuration. Themethod of Examples 28-46 also optionally includes selecting a secondelectrode configuration, calculating a second estimated defibrillationthreshold for the second electrode configuration, comparing the secondestimated defibrillation threshold to another estimated defibrillationthreshold, and selecting an estimated defibrillation threshold using atleast one of the second estimated defibrillation threshold and the otherestimated defibrillation threshold.

In Example 48, the method of Examples 28-47 optionally includescomparing at least one of the electric field detected at the secondthoracic location to at least one previous electric field detected atthe second thoracic location to detect a change in the detected electricfield at the second thoracic location, the electric field detectedbetween the third thoracic location and the fourth thoracic location toat least one previous electric field detected between the third thoraciclocation and the fourth thoracic location to detect a change in thedetected electric field between the third thoracic location and thefourth thoracic location, and the estimated defibrillation threshold toa previous estimated defibrillation threshold to detect a change in theestimated defibrillation threshold.

In Example 49, the method of Examples 28-48 optionally includesdetecting a change in the estimated defibrillation threshold using atleast one of the detected change in the detected electric field at thesecond thoracic location and the detected change in the electric fieldbetween the third thoracic location and the fourth thoracic location.

In Example 50, the method of Examples 28-49 optionally includesproviding a notification using information about at least one detectedelectric field.

In Example 51, the method of Examples 28-50 optionally includes at leastone of sensing a heart signal of a heart and sensing a respirationsignal, and wherein delivering the first nondefibrillating andnonfibrillation-inducing energy to the first thoracic location includesdelivering at a specified portion of at least one of the heart signal ofthe heart and the respiration signal.

In Example 52, the method of Examples 28-51 optionally includes at leastone of sensing a heart signal of a heart and sensing a respirationsignal, and wherein detecting the electric field at the second thoraciclocation or detecting the electric field between the third thoraciclocation and the fourth thoracic location includes detecting at aspecified portion of at least one of the heart signal of the heart andthe respiration signal.

In Example 53, the method of Examples 28-52 optionally includescomparing the estimated defibrillation threshold to a threshold.

In Example 54, the delivering the first nondefibrillating andnonfibrillation-inducing energy to the first thoracic location,detecting the electric field at the second thoracic location, anddetecting the electric field between the third thoracic location and thefourth thoracic location of Examples 28-53 optionally includes using atleast one lead in a first lead configuration. The method of Examples28-53 also optionally includes using at least one lead in a second leadconfiguration, if the estimated defibrillation threshold meets orexceeds the threshold, to calculate a second estimated defibrillationthreshold, and comparing the second estimated defibrillation thresholdto the threshold.

In Example 55, the method of Examples 28-54 optionally includesproviding a notification using information about at least one detectedelectric field.

This overview is intended to provide an overview of the subject matterof the present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the subjectmatter of the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralscan describe substantially similar components throughout the severalviews. Like numerals having different letter suffixes can representdifferent instances of substantially similar components. The drawingsillustrate generally, by way of example, but not by way of limitation,various embodiments discussed in the present document.

FIG. 1 illustrates generally an example of a system including animplantable medical device, which includes a first energy deliverycircuit, a first electric field detector, a second electric fielddetector, and a controller.

FIG. 2 illustrates generally an example of portions of a systemincluding an implantable device, a first terminal, the first terminalcoupled to a first lead, the first lead having multiple electrodes, anda second terminal, the second terminal coupled to a second lead, thesecond lead having multiple electrodes.

FIG. 3 illustrates generally an example of portions of a systemincluding a first lead, the first lead having multiple electrodes, and asecond lead, the second lead having multiple electrodes.

FIG. 4 illustrates generally an example of portions of a systemincluding a controller and a notification module.

FIG. 5 illustrates generally an example of portions of a systemincluding a controller, a heart signal sensing circuit, and arespiration sensor.

FIG. 6 illustrates generally an example of a method including deliveringa first energy to at least one first thoracic location, detecting afirst electric field at at least one second thoracic location, anddetecting a second electric field between a third thoracic location anda fourth thoracic location. The method further includes calculating anestimated defibrillation threshold using the delivered first energy, thedetected first electric field, and the detected second electric field.

FIG. 7 illustrates generally an example of portions of a methodincluding calculating an estimated defibrillation threshold using thedelivered first energy and the detected first electric field. The methodfurther includes calculating an adjusted estimated defibrillationthreshold using the estimated defibrillation threshold and the detectedsecond electric field.

FIG. 8 illustrates generally an example of a portion of a methodincluding comparing an estimated defibrillation threshold to a specifiedvalue.

FIG. 9 illustrates generally an example of portions of a methodincluding delivering a first energy, detecting a first electric field,and detecting a second electric field using at least one electrode in afirst electrode configuration. The method further includes calculating asecond estimated defibrillation threshold using at least one electrodein a second electrode configuration, and comparing the second estimateddefibrillation threshold to another estimated defibrillation threshold.The method further includes selecting an electrode configuration usingat least one of the second estimated defibrillation threshold and theother estimated defibrillation threshold.

FIG. 10 illustrates generally an example of a portion of a methodincluding detecting a change in at least one of the detected firstelectric field, the detected second electric field, and the estimateddefibrillation threshold.

FIG. 11 illustrates generally an example of a portion of a methodincluding providing a notification using information about at least oneestimated defibrillation threshold or a detected electric field.

FIG. 12 illustrates generally an example of portions of a methodincluding sensing at least one of a heart signal and a respirationsignal. The method further includes delivering a first energy at aspecified portion of at least one of the heart signal and therespiration signal.

FIG. 13 illustrates generally an example of portions of a methodincluding sensing at least one of a heart signal and a respirationsignal. The method further includes detecting a first electric field ora second electric field at a specified portion of at least one of theheart signal and the respiration signal.

FIG. 14 illustrates generally an example of portions of a methodincluding delivering a first energy, detecting a first electric field,and detecting a second electric field between using at least one lead ina first lead configuration. The method further includes calculating asecond estimated defibrillation threshold using at least one lead in asecond lead configuration, and comparing the second estimateddefibrillation threshold to a specified value. The method furtherincludes providing a notification using information about at least oneestimated defibrillation threshold or a detected electric field.

DETAILED DESCRIPTION

The following detailed description includes references to theaccompanying drawings, which form a part of the detailed description.The drawings show, by way of illustration, specific embodiments in whichthe invention may be practiced. These embodiments, which are alsoreferred to herein as “examples,” are described in enough detail toenable those skilled in the art to practice the invention. Theembodiments may be combined, other embodiments may be utilized, orstructural, logical and electrical changes may be made without departingfrom the scope of the present invention. The following detaileddescription is, therefore, not to be taken in a limiting sense, and thescope of the present invention is defined by the appended claims andtheir equivalents.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one. In this document, the term“or” is used to refer to a nonexclusive or, such that “A or B” includes“A but not B,” “B but not A,” and “A and B,” unless otherwise indicated.Throughout this document, a “user” refers to a physician or othercaregiver who examines, treats, or contacts a subject of the typereferred to in this document. Also throughout this document, internallocations or regions include subcutaneous locations or regions.Furthermore, all publications, patents, and patent documents referred toin this document are incorporated by reference herein in their entirety,as though individually incorporated by reference. In the event ofinconsistent usages between this document and those documents soincorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

Generally, an estimated defibrillation threshold energy can bedetermined using an applied electric field strength in a target regionof the heart. In order to ensure the efficacy of the defibrillation, toincrease or maximize the longevity of the source of energy, or to reducemyocardial energy, the estimated defibrillation threshold can bedetermined so that the defibrillation energy can be safely set above aspecified value, such as to include a safety margin, but low enough soas to not waste energy, shorten the usable life of the implanted device,or exceed the capabilities of an implanted device.

In an example, an energy can be delivered at a first thoracic location,such as a location in, on, or near a first chamber of the heart. In anexample, the first thoracic location can include a right ventricle(“RV”) of the heart, a superior vena cava, an internal pectoral region,or an internal abdominal region. The energy delivered at the firstthoracic location can include a nondefibrillating ornonfibrillation-inducing energy. An electric field can be detected at asecond thoracic location in or near the target region of the heart. Inan example, the target region of the heart can include in, on, or nearthe left apical region of the heart, such as the left apical region ofthe left ventricle (“LV”) of the heart, or a left free lateral wall,such as the left free lateral wall of the left ventricle of the heart.The electric field detected at the second thoracic location can be usedto estimate the defibrillation threshold energy that will create thedesired electric field strength in the target region. In an example, theestimated defibrillation threshold, such as an estimated ventriculardefibrillation threshold or an estimated atrial defibrillationthreshold, energy can be determined using the desired, or “target”,electric field strength, e.g., 5 volts/cm, the energy delivered at thefirst thoracic location, and the electric field detected at the secondthoracic location.

However, in this example, the electric field detected at the secondthoracic location can vary with lead location. Generally, electric fieldintensity decreases as the distance from the energy source increases. Ifthe lead location or the electrode location at the second thoraciclocation is close to the energy delivery source, then the electric fielddetected at the second thoracic location will generally be larger thanthe electric field in or near the target region of the heart, such asin, on, or near the left apical region of the heart or the left freelateral wall of the heart. In this example, using the electric fielddetected at the second thoracic location could underestimate theestimated defibrillation threshold.

Thus, in an example, an electric field can be detected between a thirdthoracic location and a fourth thoracic location. The third thoraciclocation can include a thoracic location at or near the first thoraciclocation, such as the right ventricle of the heart, and the fourththoracic location can include a thoracic location at or near the secondthoracic location, such as at least one of left apical region of theheart and a left ventricular free lateral wall of the heart. Theelectric field detected between the third thoracic location and thefourth thoracic location can be indicative of the distance between thethird thoracic location and the fourth thoracic location. Or, theelectric field detected between the third thoracic location and thefourth thoracic location can be used to accommodate distance variationbetween the third thoracic location and the fourth thoracic location. Inan example, an estimated atrial or ventricular defibrillation thresholdenergy can be determined using the desired, or “target”, electric fieldstrength, e.g., 5 volts/cm, the electric field detected at the firstthoracic location, the electric field detected at the second thoraciclocation, and the electric field detected between the third thoraciclocation and the fourth thoracic location. In an example, using theelectric field detected at the second thoracic location or the electricfield detected between the third thoracic location and the fourththoracic location can avoid reliance on fluoroscopic distancemeasurement or electric field modeling computations, can account forvariation in lead or electrode location, or can account for vasculaturedifference between subjects.

An change in a defibrillation threshold or an electric field (such asthe electric field detected between the third thoracic location and thefourth thoracic location) can be indicative of hypertrophy, ventricledilation, ischemia, myocardial infarction, scar tissue, leaddislodgement, or subject condition change. In an example, when a changein the electric field is detected, when estimated defibrillationthreshold is detected, or when the estimated defibrillation thresholdvalue meets or exceeds a particular threshold value, a defibrillationenergy can be increased or decreased, or a notification, such as awarning or other notification, can be delivered.

FIG. 1 illustrates generally an example of a system 100 including animplantable medical device 105. The implantable medical device 105generally includes a first energy delivery circuit 110, a first electricfield detector 115, a second electric field detector 120, and acontroller 125. In certain examples, the controller 125 can be animplantable component external to the implantable medical device 105, anexternal component, or a combination or permutation of an implantablecomponent and an external component. In other examples, some or all ofthe functionality of the first energy delivery circuit 110, the firstelectric field detector 115, or the second electric field detector 120,can be implemented using the controller 125.

In this example, the first energy delivery circuit 110 can be configuredto deliver a first energy to a first thoracic location of a subject. Inan example, the first energy delivery circuit 110 can be configured todeliver a nondefibrillating or nonfibrillation-inducing energy to thesubject. In other examples, other energies can be configured to bedelivered to the subject, such as a defibrillating energy, afibrillation-inducing energy, a pacing energy, or other energyconfigured to be delivered to the subject. In an example, the firstenergy delivery circuit 110 can include at least one of a voltage sourceand a current source. In certain examples, the first energy deliverycircuit 110 can include a bradycardia pacemaker, a cardiacresynchronization therapy (CRT) device, an antitachycardia pacemaker, acardioverter, a defibrillator, a combination pacemaker/defibrillator, adrug delivery device, or other implantable or external device capable ofdelivering an energy to the subject.

In an example, the first thoracic location can include one or more thanone thoracic location. The first thoracic location can include at leastone thoracic location in, on, or near a first chamber of a heart, suchas at least one of a right ventricle of the heart, a right atrium of theheart, a superior vena cava, an internal pectoral region of the thorax,and an internal abdominal region. In other examples, the first thoraciclocation can include any location capable of receiving energy from thefirst energy delivery circuit 110, such as an external thoracic locationor other thoracic location capable of receiving energy.

In the example of FIG. 1, the first electric field detector 115 can beconfigured to detect a first electric field at a second thoraciclocation. In an example, the first electric field can include theelectric field generated from the delivered first energy from the firstenergy delivery circuit 110. In an example, the second thoracic locationcan include one or more than one thoracic location. The second thoraciclocation can include a target region of the heart. Generally, the targetregion of the heart can be considered to be the region of the hearthaving the weakest electric field intensity in response to a deliveredenergy. In this example, the target region of the heart can beconsidered to be the region of the heart having the weakest electricfield intensity in response to the delivered first energy. In anexample, the second thoracic location can include one or more locationsin, on, or near at least one of an apical region of the heart and alateral wall of the heart, such as in, on, or near at least one of aleft apical region of the heart and a left ventricular free lateral wallof the heart.

In an example, the second electric field detector 120 can be configuredto detect a second electric field between a third thoracic location anda fourth thoracic location. The third thoracic location can include oneor more than one thoracic location at or near the first thoraciclocation, such as at or near the right ventricle of the heart. Thefourth thoracic location can include one or more than one thoraciclocation at or near the second thoracic location, such as at or near thetarget region of the heart, e.g., in, on, or near at least one of a leftapical region of the heart and a left ventricular free lateral wall ofthe heart. In an example, the detected second electric field can beindicative of the distance between the third thoracic location and thefourth thoracic location. Or, the detected second electric field can beused to accommodate distance variation between the third thoraciclocation and the fourth thoracic location.

In an example, the first electric field detector 115 can include thesecond electric field detector 120, or the second electric fielddetector 120 can include the first electric field detector 115.

In the example of FIG. 1, the controller 125 can be communicativelycoupled to the first energy delivery circuit 110, the first electricfield detector 115, and the second electric field detector 120. Incertain examples, the controller 125 can be configured to sendinformation to, or to receive information from, the first energydelivery circuit 110. Such information can include the amplitude,magnitude, or value of the delivered first energy. The controller 125can also be configured to send information to, or receive informationfrom, the first electric field detector 115. Such information caninclude the electric field detected at the second thoracic location. Thecontroller 125 can also be configured to send information to, or receiveinformation from, the second electric field detector 120. Suchinformation can include the electric field detected between the thirdthoracic location and the fourth thoracic location.

Generally, the controller 125 can be configured to calculate anestimated defibrillation threshold using the information sent to, orreceived from, the first energy delivery circuit 110. Such informationcan include information about the nondefibrillating ornonfibrillation-inducing delivered first energy delivered. The estimateddefibrillation threshold calculation can also use the informationreceived from the first electric field detector 115. Such informationcan include information about the detected first electric field. Theestimated defibrillation threshold calculation can also use theinformation received from the second electric field detector 120. Suchinformation can include information about the detected second electricfield. The estimated defibrillation threshold can be thought of as theestimated threshold amount of energy needed to terminate a fibrillation.

In an example, the controller 125 can be configured to calculate anestimated defibrillation threshold, such as a first estimateddefibrillation threshold, using the information sent to, or receivedfrom, the first energy delivery circuit 110. Such information caninclude information about the nondefibrillating ornonfibrillation-inducing delivered first energy. The estimateddefibrillation threshold can also be calculated using the informationreceived from the first electric field detector 115. Such informationcan include information about the electric field detected at the secondthoracic location. In another example, the controller 125 can beconfigured to calculate an adjusted estimated defibrillation threshold,such as by using an estimated defibrillation threshold and theinformation received from the second electric field detector 120, suchas the electric field detected between the third thoracic location andthe fourth thoracic location.

In other examples, the controller 125 can be configured to detect achange in at least one value. The at least one value can include atleast one of an estimated defibrillation threshold, information from thefirst electric field detector 115 (e.g., the detected first electricfield), and information from the second electric field detector 120(e.g., the detected second electric field). Generally, detecting achange in the at least one value can be used to detect a change in theestimated defibrillation threshold. It can also be used to detect achange in the estimated defibrillation threshold without calculating orrecalculating the estimated defibrillation threshold, such as bydetecting a change in the detected first electric field, detecting achange in the detected second electric field, etc. A change in theestimated defibrillation threshold, a change in the detected firstelectric field, a change in the detected second electric field, etc.,can be indicative of a subject condition change, a system configurationchange (e.g., electrode or lead tissue build-up, electrode or leaddislodgment, electrode or lead failure, other circuitry failure, etc.),or other change. In an example, the change in the at least one value canbe detected by comparing the at least one value to a different value,such as a specified value (e.g., a specified threshold, an absolutethreshold, a device specific threshold, a safety-margin threshold,etc.), baseline, or previous or subsequent information about the atleast one value.

FIG. 2 illustrates generally an example of portions of a system 200including an implantable medical device 205, a first lead 210, a secondlead 215, and a heart 255. The implantable medical device 205 caninclude a housing 206, a header 207, a “can” electrode 211, a firstterminal 208 configured to couple the first lead 210 to the implantablemedical device 205, and a second terminal 209 configured to couple thesecond lead 215 to the implantable medical device 205. The first lead210 can include a first electrode 220 configured to be located in thesuper vena cava 270 of the heart 255, a second electrode 225 configuredto be located in the right ventricle 260 of the heart 255, and a thirdelectrode 230 configured to be located in the right ventricle 260. Thesecond lead 215 can include a fourth electrode 235 configured to belocated in the left ventricle 265 of the heart 255, a fifth electrode240 configured to be located in the left ventricle 265, a sixthelectrode 245 configured to be located in the left ventricle 265, and aseventh electrode 250 configured to be located in the left ventricle265.

In an example, the implantable medical device 205 can include a cardiacrhythm management device. The implantable medical device 205 can includethe first energy delivery circuit 110, the first electric field detector115, the second electric field detector 120, or the controller 125.

In an example, the implantable medical device 205 can include a housing206. Generally, the exterior of the housing 206 (also referred to as a“case” or “can”) can include a conductive metal, such as titanium. In anexample, the housing 206 can act as an electrode (e.g., a “can”electrode 211).

In an example, the implantable medical device 205 can include a header207. Generally, the header 207 can be formed using an insulativematerial, such as molded plastic. The header 207 can include at leastone receptacle, such as the first terminal 208 or the second terminal209, to receive at least one lead, such as the first lead 210 or thesecond lead 215. In an example, the header 207 can also include anelectrode, such as an indifferent electrode. In certain examples, anelectrode located on the implantable medical device 205, such as the“can” electrode 211 or the indifferent electrode, can be electricallyconnected to another electrode from the system 200, e.g., the firstelectrode 220, the second electrode 225, etc.

In an example, the first lead 210 or the second lead 215 can beconfigured to couple, such as electrically couple, the implantablemedical device 205 to at least one thoracic location, such as the firstthoracic location, the second thoracic location, the third thoraciclocation, or other thoracic location. In an example, the first lead 210or the second lead 215 can be configured to be located in at least aportion of the heart 255.

In an example, the first lead 210 can be configured to electricallyconnect the implantable medical device 205 to the super vena cava 270,the right atrium, or the right ventricle 260 using at least oneelectrode, such as the first electrode 220, the second electrode 225, orthe third electrode 230. In certain examples, the first lead 210 canelectrically connect the implantable medical device 205 to the supervena cava 270 or the right atrium using the first electrode 220, or tothe right ventricle using the second electrode 225 or the thirdelectrode 230. In certain examples, the first electrode 220 or thesecond electrode 225 can include a coil-type electrode. In an example,the coil type electrode can have a macroscopic surface areaapproximately between 2 square centimeters and 20 square centimeters. Incertain examples, the third electrode 230 can include a tip electrode,or the third electrode 230 can be configured to be disposed at the apexof the right ventricle 260. In an example, one or more than oneelectrode, such as the first electrode 220, the second electrode 225, orthe third electrode 230, can be electrically connected or can beconfigured to operate independently.

In an example, the second lead 215 can be configured to electricallyconnect the implantable medical device 205 to the left ventricle 265using at least one electrode, such as the fourth electrode 235, thefifth electrode 240, the sixth electrode 245, or the seventh electrode250. In certain examples, the fourth electrode 235, the fifth electrode240, the sixth electrode 245, or the seventh electrode 250 can be sizedor shaped for implementation in or on the left region of the heart, suchas in or on the left apical region or the left ventricular free lateralwall or the left posterior region of the heart 255. In an example, theseventh electrode 250 can include a tip electrode. In certain examples,the seventh electrode 250 can be configured to be disposed at the apexof the left ventricle 265 or at or near the left ventricular freelateral wall of the heart 255. In an example, one or more than oneelectrode, such as the fourth electrode 235, the fifth electrode 240,the sixth electrode 245, or the seventh electrode 250, can beelectrically connected or can be configured to operate independently.

FIG. 3 illustrates generally an example of portions of a system 300including a first lead 310, a second lead 315, and a heart 355. Thefirst lead 310 can include a first electrode 320 configured to belocated in the super vena cava 370, a second electrode 325 configured tobe located in the RV 360, and a third electrode 330 configured to belocated in the RV 360. The second lead can include a fourth electrode335 configured to be located in the LV 365 and a fifth electrode 340configured to be located in the LV 365. Generally, the second lead 315can be configured to be located in, on, or near a left apical region ofthe heart or a left ventricular free lateral wall of the heart.

FIG. 4 illustrates generally an example of portions of a system 400including a controller 425 and a notification module 426. In an example,some or all of the functionality of the notification module 426 can beimplemented in the controller 425.

In an example, the notification module 426 can be communicativelycoupled to the controller 425. The notification module 426 can beconfigured to send information to, or to receive information from, thecontroller 425. Such information can include the estimateddefibrillation threshold, information from the first electric fielddetector 115, information from the second electric field detector 120,etc. In an example, the notification module 426 can be configured tocommunicate information from the controller 425, or other component,e.g., the first electric field detector 115, the second electric fielddetector 120, etc., to a user, to a subject, or to another device, suchas an external programmer. In an example, the notification module 426can be configured to communicate with a remote data server or a userinterface (e.g., such as a LATITUDE or other patient management systemwith a remote user interface). In another example, the notificationmodule 426 can be configured to communicate to an external device, suchas an external repeater or a remote server, which can be configured tocommunicate, such as by an e-mail or other communication, to the user.In another example, a notification, such as audible notification (e.g.,a buzz, bell, or other sound) or mechanical notification (e.g., avibration), can be used to notify the subject.

FIG. 5 illustrates generally an example of portions of a system 500including a controller 525, a heart signal sensing circuit 530, and arespiration sensor 535. In certain examples, some or all of thefunctionality of the heart signal sensing circuit 530 or the respirationsensor 535 can be implemented in the controller 525.

In certain examples, an energy delivery circuit, such as the firstenergy delivery circuit 110, can be configured to deliver an energy at aspecified portion of the heart signal, such as at the end of diastole orother portion of the heart signal, or at a specified portion of therespiration signal, such as at the transition from inspiration toexpiration or other portion of the respiration signal, including anaverage respiration signal, using a controller, such as the controller525.

In this example, the heart signal sensing circuit 530 can be configuredto sense a heart signal of a subject. The heart signal can include anysignal indicative of the electrical or mechanical cardiac activity ofthe heart, e.g., an electrocardiogram (“ECG”) signal, an impedancesignal, an acceleration signal, etc. The heart signal sensing circuit530 can be configured to produce an encoded representation of a heartsignal, such as an electrically or optically encoded heart signal, thatincludes information about the actual heart signal of the subject. Theheart signal sensing circuit 530 can include any device configured tosense the cardiac activity of the subject. In certain examples, theheart signal sensing circuit 530 can include a cardiac signal sensor,such as one or more than one electrode or lead configured to sense oneor more than one depolarization, or an impedance sensor or a mechanicalsensor, such as an accelerometer, to sense one or more than onecontraction.

In an example, the respiration sensor 535 can be configured to sense arespiration signal of the subject. The respiration signal can includeany signal indicative of the respiration of the subject, such asinspiration, expiration, or any combination, permutation, or componentof the respiration of the subject. The respiration sensor 535 can beconfigured to produce a respiration signal, such as an electrical oroptical respiration signal, that includes information about therespiration of the subject. In certain examples, the respiration sensor535 can include an implantable sensor including at least one of anaccelerometer, an impedance sensor, and a pressure sensor.

In an example, the respiration sensor 535 can include an accelerometerconfigured to sense an acceleration signal indicative of a cyclicalvariation indicative of respiration, such as that disclosed in thecommonly assigned Kadhiresan et al. U.S. Pat. No. 5,974,340 entitled“APPARATUS AND METHOD FOR MONITORING RESPIRATORY FUNCTION IN HEARTFAILURE PATIENTS TO DETERMINE EFFICACY OF THERAPY,” (herein “Kadhiresanet al. '340”) which is hereby incorporated by reference in its entirety,including its disclosure of using an accelerometer to detectrespiration. In another example, the respiration sensor 535 can includea vibration sensor, such as that disclosed in the commonly assignedHatlestad et al. U.S. Pat. No. 6,949,075 entitled “APPARATUS AND METHODFOR DETECTING LUNG SOUNDS USING AN IMPLANTED DEVICE,” (herein “Hatlestadet al. '075”) which is hereby incorporated by reference in its entirety,including its disclosure of using a vibration sensor to detectrespiration. In other examples, other accelerometer configurations canbe used to sense the respiration signal.

In another example, the respiration sensor 535 can include an impedancesensor configured to sense an impedance signal indicative ofrespiration, such as that disclosed in the commonly assigned Kadhiresanet al. '340, incorporated by reference in its entirety. In anotherexample, the respiration sensor 535 can include a transthoracicimpedance sensor, such as that disclosed in the commonly assignedHartley et al. U.S. Pat. No. 6,076,015 entitled “RATE ADAPTIVE CARDIACRHYTHM MANAGEMENT DEVICE USING TRANSTHORACIC IMPEDANCE,” which is herebyincorporated by reference in its entirety, including its disclosure ofusing a thoracic impedance sensor to detect respiration. In otherexamples, other impedance sensor configurations can be used to sense therespiration signal.

In another example, the respiration sensor 535 can include a pressuresensor configured to sense a pressure signal indicative of respiration,such as that disclosed in the commonly assigned Hatlestad et al. '075,incorporated by reference in its entirety, including its disclosure ofsensing a pressure signal indicative of respiration. In other examples,other pressure sensor configurations, such as a pulmonary arterypressure sensor, a ventricular pressure sensor, a thoracic pressuresensor, etc., can be used to sense a respiration signal.

In the example of FIG. 5, the controller 525 can be communicativelycoupled to the heart signal sensing circuit 530 and the respirationsensor 535. In certain examples, the controller 525 can be configured toreceive information from the heart signal sensing circuit 530, such asthe heart signal, or the controller 525 can be configured to receiveinformation from the respiration sensor 535, such as the respirationsignal.

In an example, the controller 525 can be configured to detect at leastone portion of the heart signal using information from the heart signalsensing circuit 530. Typically, the at least one portion of the heartsignal feature can include at least one feature or component of an ECGsignal, e.g., at least one feature or component of a P-wave, at leastone feature or component of a Q-wave, at least one feature or componentof a R-wave, at least one feature or component of a S-wave, at least onefeature or component of a R-wave, or any combination or permutation offeatures or components of the ECG signal, or any mechanical cardiacfeatures of a pressure signal, an impedance signal, or an accelerationsignal indicative of the cardiac activity of the subject.

In an example, the controller 525 can be configured to detect at leastone portion of at least one phase of the respiration signal usinginformation from the respiration sensor 535. In certain examples, the atleast one portion of the at least one phase of the respiration signalcan include at least one portion of at least one of an inspiration, anexpiration, a transition between inspiration and expiration, and atransition between expiration and inspiration.

In an example, the controller 525 can be configured to send information,such as information from the heart signal, e.g., the at least onefeature or component of the R-wave, or information from the respirationsignal, e.g., the at least one portion of an inspiration, to the firstenergy delivery circuit 110. In another example, the controller 525 canbe configured to send information, such as information from the heartsignal, e.g., the at least one feature of component of the R-wave, orinformation from the respiration signal, e.g., the at least one portionof an inspiration, to the first electric field detector 115 or thesecond electric field detector 120.

In other examples, an energy detector, such as the first electric fielddetector 115 or the second electric field detector 120, can beconfigured to sense an energy, such as an electric field at the secondthoracic location or an electric field between the third thoraciclocation and the fourth thoracic location, at a specified portion of theheart signal, such as at the end of diastole or other portion of theheart signal, or at a specified portion of the respiration signal, suchas at the transition from inspiration to expiration or other portion ofthe respiration signal, using a controller, such as the controller 525.Generally, sensing information at a specified portion of the heartsignal or the respiration signal can reduce variation otherwise presentdue to heart activity or respiration activity.

FIG. 6 illustrates generally an example of a method 600 includingdelivering a first energy to at least one first thoracic location,detecting a first electric field at at least one second thoraciclocation, and detecting a second electric field between a third thoraciclocation and a fourth thoracic location. The method 600 further includescalculating an estimated defibrillation threshold using the deliveredfirst energy, the detected first electric field, and the detected secondelectric field.

At 605, a first energy can be delivered to at least one first thoraciclocation. In an example, the first energy can be delivered using thefirst energy delivery circuit 110.

In an example, at 605, the first energy can be delivered to the firstthoracic location using the first lead 210. In an example, the firstenergy can be delivered using the first electrode 220 and the secondelectrode 225, such as by delivering the first energy between the firstelectrode 220 and the second electrode 225. In other examples, otherleads, electrodes, or devices can be used to deliver the first energy tothe at least one first thoracic location.

At 610, a first electric field can be detected at at least one secondthoracic location. In an example, the first electric field can includethe electric field generated from the delivered first energy from thefirst energy delivery circuit 110. In an example, the first electricfield can be detected using the first electric field detector 115.

In an example, at 610, the first electric field can be detected at thesecond thoracic location using the second lead 215. In an example, thefirst electric field can be detected using at least one electrode, suchas by detecting the electric field between the fourth electrode 235 andthe fifth electrode 240. In other examples, other electrodes, such asthe sixth electrode 245 or the seventh electrode 250, or a combinationof multiple electrodes (e.g., two or more electric fields detected usingthree or more electrodes synthesized to be indicative of the firstelectric field) can be used to detect the first electric field.

At 615, a second electric field can be detected between a third thoraciclocation and a fourth thoracic location. In an example, the secondelectric field can include the electric field generated from thedelivered first energy from the first energy delivery circuit 110. In anexample, the second electric field can be detected using the secondelectric field detector 120.

In an example, at 615, the second electric field can be detected usingat least one electrode located at or near the third thoracic locationand at least one electrode located at or near the fourth thoraciclocation, such as by detecting the electric field between the thirdelectrode 230 and the seventh electrode 250.

In other examples, the second electric field can include the electricfield generated from other delivered energy, such as a second energydelivered from a second energy delivery circuit. In an example, thefirst energy delivery circuit 110 can include the second energy deliverycircuit. In other examples, the second energy can be deliveredseparately from the first energy, such as by using a separate device, orby delivering the second energy at a separate time than the firstenergy.

In an example, the second electric field can include an electric fielddetected between a RV electrode and a LV electrode, or V_(LV-RV). In anexample, the V_(LV-RV) can be detected using the third electrode 230 andthe seventh electrode 250.

Generally, the estimation error (“V_(err)”) is the error between ashock-determined defibrillation threshold, or other known or establisheddefibrillation threshold (“VDFT_(real)”), and an estimateddefibrillation threshold (“VDFT_(est)”). The V_(err) can be defined as aratio of the difference between the VDFT_(est) and the VDFT_(real) overthe VDFT_(real):

$V_{err} = {\frac{\left( {{VDFT}_{est} - {VDFT}_{real}} \right)}{{VDFT}_{real}}.}$

The present inventor has recognized, among other things, that theV_(err) generally correlates to the electric field detected between thethird thoracic location and the fourth thoracic location, such asV_(LV-RV). Generally, the second electric field decreases as thedistance between the third thoracic location and the fourth thoraciclocation decreases. The distance between the third thoracic location andthe fourth thoracic location can be indicative of the location of the alead in the LV, such as the second lead 215. In an example, a decreasein the second electric field can be indicative of an increase in thedistance between the LV lead and the target region of the heart. As thedistance between the LV lead and the target region of the heartincreases, the VDFT_(est) can be underestimated. Thus, the secondelectric field can be used to accurately estimate a defibrillationthreshold.

At 620, an estimated defibrillation threshold can be calculated usingthe delivered first energy, the detected first electric field, and thedetected second electric field. In an example, the estimateddefibrillation threshold can be calculated using the controller 125.

In an example, the estimated defibrillation threshold can include afirst estimated defibrillation threshold (“VDFT1 _(est)”). In anexample, at 620, the VDFT1 _(est) can be calculated by multiplying thedelivered first energy (“V₁”) by a ratio of the desired, or “target”,electric field strength (“A”), and the detected first electric field(“V₂”), such as the gradient of the detected first electric field, andthen multiplying that result by a function of the electric fielddetected between the third thoracic location and the fourth thoraciclocation (“V₃₋₄”):

${{VDFT}\; 1_{est}} = {V_{1}\frac{A}{\nabla V_{2}}{\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}.}}$In this example, the V₃₋₄ is generally correlated to a defibrillationthreshold estimation error.

Generally, the desired, or “target”, electric field strength is thevalue of the minimal potential gradient for a successful defibrillation.In an illustrative example, the desired electric field strength can be 5volts/cm. In other examples, the desired electric field strength can beselected at any desired value, which will generally be capable ofreliably converting an abnormal heart rhythm to normal heart rhythm. Incertain examples, the desired electric field strength can be selectedusing a target voltage gradient or a target voltage gradient and asafety margin. The safety margin generally includes a margin, such as a10 joule margin, above the minimum estimated amount of energy requiredto convert an abnormal heart rhythm to normal heart rhythm. Generally,calculating the estimated defibrillation threshold with the safetymargin increases the probability that the calculated defibrillationthreshold will produce the desired results.

In this example, a and b are coefficients. The coefficients a and b aregenerally calculated using a relationship between the V₃₋₄ and adefibrillation threshold estimation error. In certain examples, thecoefficients a and b can be calculated individually for each subject,such as by using information from a past defibrillation threshold, thecoefficients a and b can be calculated or established for a certainsubject population, such as for subjects having a specific condition orrelated conditions, or for subjects with similar attributes, or thecoefficients a and b can be calculated or established for an entiresubject population, such as by using information from one or more thanone individually calculated coefficient. In other examples, othercoefficients can be calculated, including a linear set of at least onecoefficient or a nonlinear set of at least one coefficient.

FIG. 7 illustrates generally an example of portions of a method 700including calculating an estimated defibrillation threshold using thedelivered first energy and the detected first electric field. The method700 further includes calculating an adjusted estimated defibrillationthreshold using the estimated defibrillation threshold and the detectedsecond electric field.

Generally, the adjusted estimated defibrillation threshold(“VDFT_(adj)”) allows the controller 125 or other device to adjust theestimated defibrillation threshold using the detected second electricfield, without calculating or recalculating the estimated defibrillationthreshold.

At 705, an estimated defibrillation threshold can be calculated usingthe delivered first energy and the detected first electric field. In anexample, the estimated defibrillation threshold can be calculated usingthe controller 125.

In an example, at 705, the estimated defibrillation threshold(“VDFT_(est)”) can be calculated by multiplying the delivered firstenergy (“V₁”) by a ratio of the desired, or “target”, electric fieldstrength (“A”), e.g., 5 volts/cm, and the detected first electric field(“V₂”), such as the gradient of the detected first electric field:

${VDFT}_{est} = {V_{1}{\frac{A}{\nabla V_{2}}.}}$

At 710, an adjusted estimated defibrillation threshold can be calculatedusing the estimated defibrillation threshold, e.g., the estimateddefibrillation threshold calculated at 705, and the detected secondelectric field.

In an example, at 710, the adjusted estimated defibrillation threshold(“VDFT_(adj)”) can be calculated by multiplying an estimateddefibrillation threshold by a function of the V₃₋₄, such as

$\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}\text{:}$

${VDFT}_{adj} = {{VDFT}_{est}{\frac{1}{\left( {{aV}_{3 - 4} + b + 1} \right)}.}}$

FIG. 8 illustrates generally an example of a portion of a method 800including comparing an estimated defibrillation threshold to a specifiedvalue.

At 805, an estimated defibrillation threshold can be compared to aspecified value. In an example, the estimated defibrillation thresholdcan be compared to the specified value in order to determine if theestimated defibrillation threshold is above or below the specifiedvalue, or to determine if the estimated defibrillation threshold haschanged. Generally, a change in the estimated defibrillation thresholdcan be indicative of a subject condition change, a system configurationchange (e.g., electrode or lead tissue build-up, electrode or leaddislodgment, electrode or lead failure, other circuitry failure, etc.),or other change.

In other examples, the detected first electric field, the detectedsecond electric field, etc., can be compared to the specific value. Theestimated defibrillation threshold can also be compared to the specifiedvalue in order to ensure that various components of the systems 100-500,such as the controller 125, the first electric field detector 115, thesecond electric field detector 120, or other component of systems100-500, are receiving, delivering, or otherwise being exposed toexpected data, expected information, or expected results. In otherexamples, other datum can be compared to the specified value, such asinformation about the detected first electric field, information aboutthe detected second electric field, or other information.

In certain examples, the specified value can include a specifiedthreshold, an absolute threshold, a device specific threshold, asafety-margin threshold, baseline, or other specified value.

FIG. 9 illustrates generally an example of portions of a method 900including delivering a first energy, detecting a first electric field,and detecting a second electric field using at least one electrode in afirst electrode configuration. The method 900 further includescalculating a second estimated defibrillation threshold using at leastone electrode in a second electrode configuration, and comparing thesecond estimated defibrillation threshold to another estimateddefibrillation threshold. The method 900 further includes selecting anelectrode configuration using at least one of the second estimateddefibrillation threshold and the other estimated defibrillationthreshold.

At 905, a first energy can be delivered, a first electric field can bedetected, and a second electric field can be detected using at least oneelectrode in a first electrode configuration. In an example, the firstelectrode configuration can be selected by the controller 125. In otherexamples, the first electrode configuration can be selected by a userand communicated to the controller 125 or to the implantable medicaldevice 105.

In an example, at 905, the first energy can be delivered using at leastone electrode, such as by using the first electrode 220 and the secondelectrode 225. The first electric field can be detected using at leastone electrode, such as by using the fourth electrode 235 and the fifthelectrode 240. The second electric field can be detected using at leastone electrode, such as by using the third electrode 230 and the seventhelectrode 250. In this example, the first electrode configuration caninclude the first electrode 220, the second electrode 225, the thirdelectrode 230, the fourth electrode 235, the fifth electrode 240, andthe seventh electrode 250. In other examples, the first electrodeconfiguration can include other electrodes, such as the sixth electrode245, the “can” electrode 211, etc.

At 910, a second estimated defibrillation threshold can be calculatedusing at least one electrode in a second electrode configuration.Generally, the second electrode configuration includes at least oneelectrode that is not included in the first electrode configuration. Inan example, the second electrode configuration can be selected by thecontroller 125. In other examples, the second electrode configurationcan be selected by a user and communicated to the controller 125 or tothe implantable medical device 105.

In an example, at 910, the first energy can be delivered to the firstthoracic location, the first electric field can be detected at thesecond thoracic location, and the second electric field can be detectedbetween the third thoracic location and the fourth thoracic locationusing the second electrode configuration. In an example, the firstelectric field can be detected using the fourth electrode 235 and thesixth electrode 245. In this example, the second electrode configurationcan include the fourth electrode 235, the sixth electrode 245, and otherelectrodes.

In an example, at 910, the second estimated defibrillation threshold canbe calculated using the second electrode configuration, like theestimated defibrillation threshold calculated at 620. In an example, thesecond estimated defibrillation threshold can be calculated using thecontroller 125.

At 915, the second estimated defibrillation threshold can be compared toanother estimated defibrillation threshold. Generally, the secondestimated defibrillation threshold is compared to the other estimateddefibrillation threshold in order to select an electrode configuration.In an example, the other estimated defibrillation threshold can includean estimated defibrillation threshold calculated using the firstelectrode configuration. In other examples, the other estimateddefibrillation threshold can include an expected estimateddefibrillation threshold, such as an average, typical, or otherestimated or known defibrillation threshold, such as the average of acertain number (e.g., 10) estimated defibrillation thresholds, theaverage of a certain number (e.g., 5) known defibrillation thresholds,etc. In certain examples, other numbers can be used, or the average,typical, or other threshold can be updated continuously. In an example,the second estimated defibrillation threshold can be compared using thecontroller 125.

At 920, an electrode configuration can be selected using at least one ofthe second estimated defibrillation threshold and the other estimateddefibrillation threshold. Generally, the electrode configurationyielding the “better” estimated defibrillation threshold (e.g., theclosest estimated defibrillation threshold to the expected estimateddefibrillation threshold) is preferred. In an example, if one or morethan one estimated defibrillation threshold is determined to be invalid(e.g., having an unrealistic result, such as an estimated defibrillationthreshold of zero volts), a valid estimated defibrillation threshold ispreferred. In certain examples, an invalid estimated defibrillationthreshold can include an estimated defibrillation threshold above anupper threshold (e.g., a specified upper threshold), a device-specificthreshold (e.g., a device specific safety margin or other threshold), oran estimated defibrillation threshold below a lower threshold (e.g., aspecified minimum threshold).

In other examples, a user can select an estimated defibrillationthreshold, or notification of an estimated defibrillation threshold,such as an estimated defibrillation threshold above or below a certainthreshold, can be provided to the user, such as by using thenotification module 426.

FIG. 10 illustrates generally an example of a portion of a method 1000including detecting a change in at least one of the detected firstelectric field, the detected second electric field, and the estimateddefibrillation threshold.

Generally, defibrillation thresholds can change over time. In certainexamples, the detected first electric field, the detected secondelectric field, or the estimated defibrillation threshold can change dueto various factors including lead migration, heart size change, or otherreasons. In an example, one or more such changes can be detected, suchas by using the controller 125.

At 1005, the change in at least one of the detected first electricfield, the detected second electric field, and the estimateddefibrillation threshold can be detected.

In an example, at 1005, the detected first electric field or thedetected second electric field can be compared to at least onepreviously detected value to detect a change in value. In otherexamples, the detected first electric field or the detected secondelectric field can be compared (such as by using the controller 125) toa patient-specific or population-derived historical baseline, to one ormore other templates.

In an example, at 1005, the estimated defibrillation threshold can becompared to a previously estimated value to detect a change in value. Inother examples, the estimated defibrillation threshold can be comparedto a baseline, such as a baseline established using a history of theestimated defibrillation threshold of the subject, of another subject,or of a population, or the estimated defibrillation threshold can becompared to other templates. In an example, the estimated defibrillationthreshold can be compared using the controller 125.

FIG. 11 illustrates generally an example of a portion of a method 1100including providing a notification using information about at least oneestimated defibrillation threshold or a detected electric field. In anexample, the notification can be provided using the notification module426.

At 1105, a notification can be provided using information about at leastone estimated defibrillation threshold or a detected electric field. Inan example, the at least one estimated defibrillation threshold caninclude the adjusted estimated defibrillation threshold or anotherestimated defibrillation threshold. In certain examples, thenotification can include the value of an estimated defibrillationthreshold, the notification can include the results of comparing anestimated defibrillation threshold to a specified value, or thenotification can include other information. In an example, the detectedelectric field can include a detected first electric field or a detectedsecond electric field. In an example, the notification can include achange in a detected electric field. A slow or consistent change in adetected electric field can be indicative of a patient-condition change(e.g., the change occurring over a long period of time, such as days,weeks, or months). A fast or abrupt change in a detected electric fieldcan be indicative of other conditions, such as lead dislodgment (e.g.,the change occurring over a short period of time, such as seconds). Inan example, the notification can be provided to a subject or a user. Inother examples, other information, such as information from thecontroller 125 or other component, can be provided.

FIG. 12 illustrates generally an example of portions of a method 1200including sensing at least one of a heart signal and a respirationsignal. The method 1200 further includes delivering a first energy at aspecified portion of at least one of the heart signal and therespiration signal. In an example, the energy delivery can be enabledusing the controller 125.

At 1205, at least one of a heart signal and a respiration signal can besensed. The heart signal can include any signal indicative of theelectrical or mechanical cardiac activity of a heart. In an example, thecardiac signal can be sensed using the heart signal sensing circuit 530.The respiration signal can include any signal indicative of therespiration of a subject, such as inspiration, expiration, or anycombination, permutation, or component of the respiration of thesubject. In an example, the respiration signal can be sensed using therespiration sensor 535.

At 1210, a first energy can be delivered at a specified portion of atleast one of the heart signal of the heart and the respiration signal.In an example, the first energy can be delivered at a specified portionof the heart signal, such as at the end of diastole or other portion ofthe heart signal, using the first energy delivery circuit 110 or otherenergy delivery circuit. In an example, at 1210, the first energy can bedelivered at a specified portion of the respiration signal, such as atthe transition from inspiration to expiration or other portion of therespiration signal, using the first energy delivery circuit 110 or otherenergy delivery circuit.

FIG. 13 illustrates generally an example of portions of a method 1300including sensing at least one of a heart signal and a respirationsignal. The method 1300 further includes detecting a first electricfield or a second electric field at a specified portion of at least oneof the heart signal and the respiration signal.

Generally, the method 1300 can enable cardiac-synchronous orrespiration-synchronous defibrillation threshold determination byenabling electric field detection at a specified portion of at least oneof the heart signal and the respiration signal. In an example, theelectric field detection can be enabled using the controller 125.

At 1305, at least one of a heart signal and a respiration signal can besensed. The heart signal can include any signal indicative of theelectrical or mechanical cardiac activity of a heart. In an example, theheart signal can be sensed using the heart signal sensing circuit 530.The respiration signal can include any signal indicative of therespiration of a subject, such as inspiration, expiration, or anycombination, permutation, or component of the respiration of thesubject. In an example, the respiration signal can be sensed using therespiration sensor 535.

At 1310, a first electric field or a second electric field can bedetected at a specified portion of at least one of the heart signal andthe respiration signal. In an example, the first electric field or thesecond electric field can be detected at a specified portion of theheart signal of the heart, such as at the end of diastole or otherportion of the heart signal, using the first electric field detector 115or the second electric field detector 120. In an example, the firstelectric field or the second electric field can be detected at aspecified portion of the respiration signal, such as at the transitionfrom inspiration to expiration or other portion of the respirationsignal, using the first electric field detector 115 or the secondelectric field detector 120.

FIG. 14 illustrates generally an example of portions of a method 1400including delivering a first energy, detecting a first electric field,and detecting a second electric field between using at least one lead ina first lead configuration. The method 1400 further includes calculatinga second estimated defibrillation threshold using at least one lead in asecond lead configuration, and comparing the second estimateddefibrillation threshold to a specified value. The method 1400 furtherincludes providing a notification using information about at least oneestimated defibrillation threshold or a detected electric field.

At 1405, a first energy can be delivered, a first electric field can bedetected, and a second electric field can be detected using at least onelead in a first lead configuration. In an example, the first leadconfiguration can be selected by the controller 125. In other examples,the first lead configuration can be selected by a user and communicatedto the controller 125 or to the implantable medical device 105.

In an example, at 1405, the first energy can be delivered using thefirst lead 210. The first electric field can be detected using thesecond lead 215. The second electric field can be detected using thefirst lead 210 and the second lead 215. In this example, the first leadconfiguration can include the first lead 210 and the second lead 215. Inother examples, the first lead configuration can include other leads.

In certain examples, the first lead configuration can include theconfiguration illustrated in FIG. 2 or FIG. 3. In other examples, otherlead configurations can be selected, including lead configurationsincluding other leads, or lead configurations having different leadlocations, such as at least one lead located in a different physicallocation (e.g., located in a different blood vessel), spatial location(such as located a certain distance from a prior location or anotherlead location), or other location.

At 1410, a second estimated defibrillation threshold can be calculatedusing at least one lead in a second lead configuration. Generally, thesecond lead configuration includes at least one lead not included in thefirst lead configuration, or the second lead configuration includes atleast one lead located in a different location as the at least one leadof the first lead configuration (e.g., located in a different physicallocation, spatial location, or other location). In an example, thesecond lead configuration can be selected by the controller 125. Inother examples, the second lead configuration can be selected by a userand communicated to the controller 125 or to the implantable medicaldevice 105.

Generally, a first energy can be delivered, a first electric field canbe detected, and a second electric field can be detected using thesecond lead configuration. In an example, at 1410, the second estimateddefibrillation threshold can be calculated using the second leadconfiguration, such as calculating the second estimated defibrillationthreshold using the delivered first energy, the detected first electricfield, and the detected second electric field from the second leadconfiguration. In an example, the second estimated defibrillationthreshold can be calculated using the controller 125.

At 1415, the second estimated defibrillation threshold can be comparedto a specified value. In an example, the second estimated defibrillationthreshold can be compared to the specified value in order to determineif the second estimated defibrillation threshold is above or below thespecified value, or to determine if the estimated defibrillationthreshold has changed. Generally, a change in the estimateddefibrillation threshold can be indicative of a subject conditionchange, a system configuration change (e.g., electrode or lead tissuebuild-up, electrode or lead dislodgment, electrode or lead failure,other circuitry failure, etc.), or other change. In other examples, thesecond estimated defibrillation threshold can be compared to thespecific value in order to ensure proper lead placement. Proper leadplacement is generally lead placement that yields a reasonable estimateddefibrillation threshold.

In certain examples, the specified value can include an average,typical, or other estimated or known defibrillation threshold. In otherexamples, the specified value can include a specified threshold, anabsolute threshold, a device specific threshold, a safety-marginthreshold, a baseline, or other specified value. In an example, theestimated defibrillation threshold can be compared to the specifiedvalue using the controller 125.

At 1420, a notification can be provided using information about at leastone estimated defibrillation threshold or a detected electric field. Incertain examples, the controller 125 or the notification module 426 canbe configured to communicate information about at least one estimateddefibrillation threshold, such as if the second estimated defibrillationthreshold meets or exceeds the specified value, to a user. In otherexamples, the controller 125 or the notification module 426 can beconfigured to communicate information about a detected electric field(e.g., the detected second electric field).

In other examples, at least one lead configuration, such as the firstlead configuration or the second lead configuration, can be selectedusing information from the controller 125 (e.g., the at least oneestimated defibrillation threshold), from the first electric fielddetector 115 (e.g., the detected first electric field), the secondelectric field detector 120 (e.g., the detected second electric field),a remote server, a user interface, or other device.

In this document, an electric field, such as the first electric field orthe second electric field, can include any electric field that can bedetected in the subject, such as an intrinsic electric field establishedby normal cardiac or other electrical activity, an electric fieldestablished by an energy delivery circuit, e.g., the first energydelivery circuit 110, or other electric field.

In the examples of FIG. 1-14, various examples, including delivering afirst energy, detecting a first electric field, detecting a secondelectric field, calculating an estimated defibrillation threshold,calculating an adjusted estimated defibrillation threshold, detecting achange in at lest one of the detected first electric field, the detectedsecond electric field, and the estimated defibrillation threshold,providing a notification, selecting an electrode configuration, sensinga heart signal of a heart, sensing a respiration signal, and selecting alead configuration are disclosed. It is to be understood that thedisclosed examples are not exclusive, and can be implemented eitheralone or in combination, or in various permutations or combinations.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. Many other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the inventionshould, therefore, be determined with reference to the appended claims,along with the full scope of equivalents to which such claims areentitled. In the appended claims, the terms “including” and “in which”are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, or process that includes elements in addition to those listedafter such a term in a claim are still deemed to fall within the scopeof that claim. Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects.

The Abstract is provided to comply with 37 C.F.R. §1.72(b), whichrequires that it allow the reader to quickly ascertain the nature of thetechnical disclosure. It is submitted with the understanding that itwill not be used to interpret or limit the scope or meaning of theclaims. Also, in the above Detailed Description, various features may begrouped together to streamline the disclosure. This should not beinterpreted as intending that an unclaimed disclosed feature isessential to any claim. Rather, inventive subject matter may lie in lessthan all features of a particular disclosed embodiment. Thus, thefollowing claims are hereby incorporated into the Detailed Description,with each claim standing on its own as a separate embodiment.

1. A system comprising: a first implantable energy delivery circuit,configured to deliver a nondefibrillating and nonfibrillation-inducingenergy to a first thoracic region, wherein the first energy deliverycircuit is configured to deliver the energy to the first thoracic regionthat includes a location in, on, or near at least one of a rightventricle of the heart, a superior vena cava, an internal pectoralregion, and an internal abdominal region; a first implantable electricfield detector, configured to detect a first electric field at a secondthoracic region including a location in, on, or near at least one of aleft apical region of the heart and a left ventricular free lateral wallof the heart; a second implantable electric field detector, configuredto detect a second electric field between a third thoracic region, whichincludes a location at or near at least a portion of the first thoracicregion, and a fourth thoracic region, which includes a location at ornear at least a portion of the second thoracic region; and animplantable or external controller, communicatively coupled to the firstenergy delivery circuit, the first electric field detector, and thesecond electric field detector, wherein the controller is configured tocalculate an estimated defibrillation threshold using the deliveredenergy, the detected first electric field, and the detected secondelectric field, wherein the estimated defibrillation threshold includesa first estimated defibrillation threshold (“VDFT1 _(est)”) calculatedusing${{{VDFT}\; 1_{est}} = {V_{1}\frac{A}{{\nabla V}\; 2}{f\left( V_{3 - 4} \right)}}},$wherein V₁ includes a value of the delivered first energy, A is adesired, or “target”, electric field strength, ∇V₂ includes the detectedfirst electric field, and V₃₋₄ includes the detected second electricfield, wherein f(V₃₋₄) is configured to adjust the ratio of V₁, A, and∇V₂.
 2. The system of claim 1, wherein the first energy delivery circuitincludes at least one of a voltage source and a current source,configured to deliver at least one of a voltage and a current using atleast one first electrode and at least one second electrode.
 3. Thesystem of claim 1, wherein the first electric field detector isconfigured to detect the first electric field at the second thoracicregion that includes a location in, on, or near the left ventricularfree lateral wall of the heart.
 4. The system of claim 1, including: atleast one lead, configured to couple at least one of the first energydelivery circuit, the first electric field detector, and the secondelectric field detector to at least one of the at least one firstthoracic region, the at least one second thoracic region, the thirdthoracic region, and the fourth thoracic region; and wherein the atleast one lead includes at least one electrode.
 5. The system of claim4, wherein the at least one electrode is in a first electrodeconfiguration; and wherein the controller is configured to calculate asecond estimated defibrillation threshold using at least one electrodein a second electrode configuration, to compare the second estimateddefibrillation threshold to another estimated defibrillation threshold,and to select an electrode configuration using at least one of thesecond estimated defibrillation threshold and the other estimateddefibrillation threshold.
 6. The system of claim 1, wherein thecontroller is configured to detect a change in at least one of thedetected first electric field, the detected second electric field, andthe estimated defibrillation threshold.
 7. The system of claim 6,wherein the controller is configured to detect a change in the estimateddefibrillation threshold using at least one of a detected change in thefirst electric field or the second electric field.
 8. The system ofclaim 1, including a notification module, communicatively coupled to thecontroller, wherein the notification module is configured to provide anotification using information from the controller.
 9. The system ofclaim 1, including: at least one of an implantable or external heartsignal sensing circuit, communicatively coupled to the controller, theheart signal sensing circuit configured to sense a heart signal of aheart, and an implantable or external respiration sensor,communicatively coupled to the controller, configured to sense arespiration signal; and wherein the first energy delivery circuit isconfigured to deliver the energy at a specified portion of at least oneof the heart signal of the heart and the respiration signal.
 10. Thesystem of claim 1, including: at least one of an implantable or externalheart signal sensing circuit, communicatively coupled to the controller,the heart signal sensing circuit configured to sense a heart signal of aheart, and an implantable or external respiration sensor,communicatively coupled to the controller, the respiration sensorconfigured to sense a respiration signal; and wherein the first electricfield detector or the second electric field detector is configured todetect an electric field at a specified portion of at least one of theheart signal of the heart and the respiration signal.
 11. The system ofclaim 1, wherein the controller is configured to compare the estimateddefibrillation threshold to a specified value.
 12. The system of claim1, wherein the first implantable electric field detector is configuredto detect, at the second thoracic region, the first electric fieldgenerated from the nondefibrillating and nonfibrillation-inducing energydelivered to the first thoracic region.
 13. The system of claim 1,wherein the second implantable electric field detector is configured todetect, between the third thoracic region and the fourth thoracicregion, the second electric field generated from the nondefibrillatingand nonfibrillation-inducing energy delivered to the first thoracicregion.
 14. A system comprising: a first implantable energy deliverycircuit, configured to deliver a nondefibrillating andnonfibrillation-inducing energy to a first thoracic region, wherein thefirst energy delivery circuit is configured to deliver the energy to thefirst thoracic region that includes a location in, on, or near at leastone of a right ventricle of the heart, a superior vena cava, an internalpectoral region, and an internal abdominal region; a first implantableelectric field detector, configured to detect a first electric field ata second thoracic region including a location in, on, or near at leastone of a left apical region of the heart and a left ventricular freelateral wall of the heart; a second implantable electric field detector,configured to detect a second electric field between a third thoracicregion, which includes a location at or near at least a portion of thefirst thoracic region, and a fourth thoracic region, which includes alocation at or near at least a portion of the second thoracic region;and an implantable or external controller, communicatively coupled tothe first energy delivery circuit, the first electric field detector,and the second electric field detector, wherein the controller isconfigured to calculate an estimated defibrillation threshold using thedelivered energy, the detected first electric field, and the detectedsecond electric field, wherein the controller is configured to calculatean initial estimated defibrillation threshold using the delivered energyand the detected first electric field, and to calculate an adjustedestimated defibrillation threshold using the initial estimateddefibrillation threshold and the detected second electric field.
 15. Thesystem of claim 14, wherein: the initial estimated defibrillationthreshold (“VDFT_(est)”) is calculated using${{VDFT}_{est} = {V_{1}\frac{A}{\nabla V_{2}}}},$ wherein V₁ includes avalue of the delivered energy, A is a desired, or “target”, electricfield strength, ∇V₂ includes the detected first electric field; and theadjusted estimated defibrillation threshold (“VDFT_(adj)”) is calculatedusing VDFT_(adj)=VDFT_(est)f(V₃₋₄), wherein V₃₋₄ includes the detectedsecond electric field.
 16. A method comprising: delivering a firstnondefibrillating and nonfibrillation-inducing energy to at least onefirst thoracic region using a first implantable energy delivery circuit,wherein delivering the first energy includes delivering the first energyin, on, or near at least one of a right ventricle of the heart, asuperior vena cava, an internal pectoral region, and an internalabdominal region; detecting a first electric field at at least onesecond thoracic region using a first implantable electric field detectorincluding a location in, on, or near at least one of a left apicalregion of the heart and a left ventricular free lateral wall of theheart; detecting a second electric field between a third thoracicregion, which is at or near the at least one first thoracic region, anda fourth thoracic region, which is at or near the at least one secondthoracic region, using a second implantable electric field detector; andcalculating, using an implantable or external controller, an estimateddefibrillation threshold using the delivered first energy, the detectedfirst electric field, and the detected second electric field, whereincalculating the estimated defibrillation threshold includes calculatinga first estimated defibrillation threshold (“VDFT1 _(est)”) using${{{VDFT}\; 1_{est}} = {V_{1}\frac{A}{{\nabla V}\; 2}{f\left( V_{3 - 4} \right)}}},$wherein V₁ includes the delivered first energy, A is a desired, or“target”, electric field strength, ∇V₂ includes a signal indicative ofthe detected first electric field, and V₃₋₄ includes a signal indicativeof the detected second electric field, wherein f(V₃₋₄) is configured toadjust the ratio of V₁, A, and ∇V₂.
 17. The method of claim 16, whereindelivering the first energy includes delivering at least one of avoltage and a current using at least one first electrode and at leastone second electrode.
 18. The method of claim 16, wherein detecting thefirst electric field includes detecting the first electric field in, on,or near the left ventricular free lateral wall of the heart.
 19. Themethod of claim 16, wherein delivering the first energy, detecting thefirst electric field, and detecting the second electric field includesusing at least one electrode in a first electrode configuration, themethod further including: calculating a second estimated defibrillationthreshold using at least one electrode in a second electrodeconfiguration; comparing the second estimated defibrillation thresholdto another estimated defibrillation threshold; and selecting anelectrode configuration using at least one of the second estimateddefibrillation threshold and the other estimated defibrillationthreshold.
 20. The method of claim 16, including detecting a change inat least one of the detected first electric field, the detected secondelectric field, and the estimated defibrillation threshold.
 21. Themethod of claim 20, including detecting a change in the estimateddefibrillation threshold using the detected change in at least one ofthe detected first electric field or the detected second electric field.22. The method of claim 16, including providing a notification usinginformation about at least one detected electric field.
 23. The methodof claim 16, including: sensing at least one of a heart signal and arespiration signal; and wherein delivering the first energy includesdelivering at a specified portion of at least one of the heart signaland the respiration signal.
 24. The method of claim 16, including:sensing at least one of a heart signal and a respiration signal; andwherein detecting the first electric field or the second electric fieldincludes detecting at a specified portion of at least one of the heartsignal and the respiration signal.
 25. The method of claim 16, includingcomparing the estimated defibrillation threshold to a specified value.26. The method of claim 25, wherein delivering the first energy,detecting the first electric field, and detecting the second electricfield includes using at least one lead in a first lead configuration,and wherein the method includes: calculating a second estimateddefibrillation threshold using at least one lead in a second leadconfiguration if the estimated defibrillation threshold meets or exceedsthe specified value; and comparing the second estimated defibrillationthreshold to the specified value.
 27. The method of claim 26, includingproviding a notification using information about at least one estimateddefibrillation threshold.
 28. The method of claim 16, wherein thedetecting the first electric field includes detecting, at the secondthoracic region, a first electric field generated from thenondefibrillating and nonfibrillation-inducing energy delivered to thefirst thoracic region.
 29. The method of claim 16, wherein the detectingthe second electric field includes detecting, between the third thoracicregion and the fourth thoracic region, a second electric field generatedfrom the nondefibrillating and nonfibrillation-inducing energy deliveredto the first thoracic region.
 30. A method comprising: delivering afirst nondefibrillating and nonfibrillation-inducing energy to at leastone first thoracic region using a first implantable energy deliverycircuit, wherein delivering the first energy includes delivering thefirst energy in, on, or near at least one of a right ventricle of theheart, a superior vena cava, an internal pectoral region, and aninternal abdominal region; detecting a first electric field at at leastone second thoracic region using a first implantable electric fielddetector including a location in, on, or near at least one of a leftapical region of the heart and a left ventricular free lateral wall ofthe heart; detecting a second electric field between a third thoracicregion, which is at or near the at least one first thoracic region, anda fourth thoracic region, which is at or near the at least one secondthoracic region, using a second implantable electric field detector; andcalculating, using an implantable or external controller, an estimateddefibrillation threshold using the delivered first energy, the detectedfirst electric field, and the detected second electric field, whereincalculating the estimated defibrillation threshold includes calculatingan initial estimated defibrillation threshold using the delivered firstenergy and the detected first electric field, the method furtherincluding calculating an adjusted estimated defibrillation thresholdusing the initial estimated defibrillation threshold and the detectedsecond field.
 31. The method of claim 30, wherein: calculating theinitial estimated defibrillation threshold (“VDFT_(est)”) includes using${{VDFT}_{est} = {V_{1}\frac{A}{\nabla\; V_{2}}}},$ wherein V₁ includesa value of the delivered first energy, A is a desired, or “target”,electric field strength, and ∇V₂ includes a signal indicative of thedetected first electric field; and calculating the adjusted estimateddefibrillation threshold (“VDFT_(adj)”) includes using:VDFT_(adj)=VDFT_(est)f(V₃₋₄), wherein V₃₋₄ includes a signal indicativeof the detected second electric field.